FDA Review Panel · CH

FDA 510(k) Chemistry Devices

FDA 510(k) Chemistry Devices - Regulatory Overview

FDA 510(k) chemistry devices cover in vitro diagnostic (IVD) instruments used in clinical laboratories. The FDA review panel code is CH.

This category includes:

  • Clinical chemistry analyzers - glucose, electrolytes, enzymes, proteins
  • Point-of-care test systems - rapid diagnostics for hospital and home use
  • Reagents and calibrators - consumables used with automated analyzers
  • Urinalysis systems - dipstick readers and urine sediment analyzers

Most devices in this panel are Class II (Special Controls) under 21 CFR Part 862. Data sourced from FDA 510(k) public files. Updated monthly.

13237
Total
13205
Cleared
191d
Avg (2y)
1976
Since
11187 Chemistry devices
1226–1250 of 11187
Cleared Nov 30, 2012
DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR
K121994 · Siemens Healthcare Diagnostics, Inc.
CDD · Radioassay, Vitamin B12 · 147d
Cleared Nov 30, 2012
GENSTRIP TEST STRIP MODEL 100-201
K103542 · Shasta Technologies, LLC
NBW · System, Test, Blood Glucose, Over The Counter · 729d
Cleared Nov 29, 2012
COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190
K122722 · Roche Diagnostics
DFC · Lipoprotein, Low-density, Antigen, Antiserum, Control · 85d
Cleared Nov 28, 2012
DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA
K122420 · Diazyme Laboratories
MRG · System, Test, Vitamin D · 111d
Cleared Nov 27, 2012
ABBOTT ARCHITECT FREE T4
K123379 · Abbott Laboratories
CEC · Radioimmunoassay, Free Thyroxine · 26d
Cleared Nov 21, 2012
ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM
K122110 · ACON Laboratories, Inc.
CGA · Glucose Oxidase, Glucose · 127d
Cleared Nov 21, 2012
AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE
K120326 · Radiometer Medical Aps
JHX · Fluorometric Method, Cpk Or Isoenzymes · 293d
Cleared Nov 20, 2012
LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA
K123198 · Bio-Rad Laboratories
JJY · Multi-analyte Controls, All Kinds (assayed) · 40d
Cleared Nov 20, 2012
RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3
K121603 · Randox Laboratories, Ltd.
JJY · Multi-analyte Controls, All Kinds (assayed) · 228d
Cleared Nov 16, 2012
ABL90 FLEX
K122729 · Radiometer Medical Aps
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 71d
Cleared Nov 09, 2012
PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
K113314 · Hmd Biomedical, Inc.
LFR · Glucose Dehydrogenase, Glucose · 366d
Cleared Oct 26, 2012
ABL90 FLEX
K122642 · Radiometer Medical Aps
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 58d
Cleared Oct 26, 2012
VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM
K122472 · Bio-Rad Laboratories, Inc., Clinical Systems Divis
LCP · Assay, Glycosylated Hemoglobin · 73d
Cleared Oct 24, 2012
VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
K120765 · Ortho-Clinical Diagnostics, Inc.
KHS · Enzymatic, Carbon-dioxide · 225d
Cleared Oct 17, 2012
LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK
K122838 · Bio-Rad Laboratories
JJY · Multi-analyte Controls, All Kinds (assayed) · 30d
Cleared Oct 12, 2012
RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS
K122398 · Siemens Healthcare Diagnostics, Inc.
JIX · Calibrator, Multi-analyte Mixture · 66d
Cleared Oct 12, 2012
GLYCOSYLATED HEMOGLOBIN ASSAY
K120199 · Beckman Coulter, Inc.
LCP · Assay, Glycosylated Hemoglobin · 263d
Cleared Oct 11, 2012
ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM
K121679 · Roche Diagnostics
NBW · System, Test, Blood Glucose, Over The Counter · 126d
Cleared Oct 05, 2012
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT
K122757 · Alfa Wassermann Diagnostic Technologies, Inc.
CHH · Enzymatic Esterase--oxidase, Cholesterol · 28d
Cleared Oct 05, 2012
EPOC CHLORIDE TEST AND EPOC CREATININE TEST
K113726 · Epocal, Inc.
CGL · Electrode, Ion Based, Enzymatic, Creatinine · 291d
Cleared Oct 03, 2012
ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II
K122858 · Elitechgroup
JFJ · Catalytic Methods, Amylase · 15d
Cleared Oct 03, 2012
ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR
K122599 · Siemens Healthcare Diagnostics, Inc.
DDR · Myoglobin, Antigen, Antiserum, Control · 37d
Cleared Sep 24, 2012
QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST
K112449 · Tianjin New Bay Bioresearch Co., Ltd.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 396d
Cleared Sep 21, 2012
DIAZYME HSCRP POC TEST KIT
K121558 · Diazyme Laboratories
DCK · C-reactive Protein, Antigen, Antiserum, And Control · 115d
Cleared Sep 20, 2012
RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3
K113720 · Randox Laboratories, Ltd.
JJY · Multi-analyte Controls, All Kinds (assayed) · 276d

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All categories 11187 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 457 JJX Single (specified) Analyte Controls (assayed And Unassayed) 382 CGA Glucose Oxidase, Glucose 298 JHI Visual, Pregnancy Hcg, Prescription Use 285 JIX Calibrator, Multi-analyte Mixture 247 CIG Diazo Colorimetry, Bilirubin 216 JIT Calibrator, Secondary 199 JLW Radioimmunoassay, Thyroid-stimulating Hormone 188 CHH Enzymatic Esterase--oxidase, Cholesterol 186 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 175 CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph 156 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 153 JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use 147 CGX Alkaline Picrate, Colorimetry, Creatinine 143